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Sponsored by: |
Scios, Inc. |
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Information provided by: | Scios, Inc. |
ClinicalTrials.gov Identifier: | NCT00653042 |
The purpose of this study is to assess the effects of nesiritide compared to placebo when given with standard of care therapies, on kidney function, heart function and the need of other treatments in heart failure patients undergoing heart bypass graft surgery that requires the use of a cardiopulmonary bypass machine (CPB pump or heart-lung machine).
Condition | Intervention | Phase |
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Coronary Artery Bypass Surgery Cardiopulmonary Bypass Coronary Artery Bypass Grafting Congestive Heart Failure Ischemic Heart Disease Coronary Heart Disease |
Drug: Nesiritide |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | A Pilot, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Nesiritide Infusion, Initiated Post-Induction of Anesthesia, in the Management of Coronary Artery Bypass Graft (CABG) Patients Requiring CardioPulmonary Bypass (CPB) |
Estimated Enrollment: | 300 |
Study Start Date: | March 2004 |
Study Completion Date: | June 2005 |
In coronary heart disease (CHD), the coronary arteries become clogged with calcium and fatty deposits. The deposits, called plaques, narrow the arteries that carry blood to the heart muscle and could cause ischemic heart disease (too little blood and oxygen reaching the heart muscle). Coronary Artery Bypass Graft (CABG) surgery is a treatment option for ischemic heart disease. CABG surgery is surgery to create new routes for blood to flow around narrowed and blocked arteries so that the heart muscle will receive needed oxygen and nutrients. Acute kidney injury is a serious risk of CABG surgery while on CPB pump (heart-lung machine), which could result from ischemia during and following surgery. This study is a double-blind (neither the patient nor the doctor knows whether the patient is assigned to receive study drug or placebo), randomized (assigned to treatment by chance), placebo-controlled (study drug results compared to placebo results) study to determine the effectiveness of nesiritide compared to placebo when given to HF patients undergoing CABG surgery requiring the use of a CPB pump
Patients will be followed through 30 days from start of study drug. All patients may receive additional standard care medications including inotropes, pressors, vasopressin, antiarrhythmics, diuretics, nitrates, and nitric oxide as needed. Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects. A follow-up communication 180 days after the start of study drug was implemented to collect mortality data.
The patients assigned to the nesiritide group will receive a continuous I.V. infusion at 0.010 mcg/kg/min of nesiritide for at least 24 hours and could be extended to up to 96 hours. The patients assigned to the placebo group will receive matching placebo.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003352 |
Study First Received: | April 1, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00653042 History of Changes |
Health Authority: | United States: Food and Drug Administration |
kidney failure Myocardial Ischemia Coronary Artery Bypass Surgery Coronary Heart Disease |
nesiritide cardiopulmonary bypass (CPB) pump heart surgery CABG |
Arterial Occlusive Diseases Natriuretic Peptide, Brain Heart Failure Heart Diseases Myocardial Ischemia Vascular Diseases Anesthetics |
Ischemia Arteriosclerosis Cardiovascular Agents Coronary Disease Coronary Artery Disease Kidney Failure |
Arterial Occlusive Diseases Natriuretic Peptide, Brain Heart Failure Heart Diseases Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Cardiovascular Agents |
Arteriosclerosis Pharmacologic Actions Coronary Disease Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Coronary Artery Disease |